The use of the EnSeal® instrument for laparoscopic supracervical hysterectomy in a randomized, single-blinded comparison to the conventional procedure. The objective of the study is to investigate if the use of the Enseal sealing instrument for supracervical hysterectomy leads to a shortening of the operation time.

Operation time [ Time Frame: Day 1 ] [ Designated as safety issue: No ]

The following times were documented: total operation time; T1 = start of the operation until cornual structures were ready to be dissected; T2 = the time from the first coagulation and cutting of the cornual structures until the complete preparation of each parametrial side directly before cervical detachment; T3 = time needed for the cervical detachment and subsequent steps (morcellation, closure of trocar sites) until the end of the surgical procedure.

Secondary Outcome Measures:

Blood loss [ Time Frame: Day 2 ] [ Designated as safety issue: No ]

The perioperative blood loss (ΔHb) was calculated using the comparison of the preoperative red blood cells (RBC) versus the RBC on the first post-operative day. The intraoperative blood loss was measured by the suction unit (categories: < 50 ml, 50 - 100 ml, > 100 ml) and by the number of applied blood transfusions.

Willingness and capability to comply with all study tests, procedures, and assessment tools

Capability of providing informed consent.

Exclusion Criteria:

History of, or evidence of, gynecologic malignancy within the past five years

Pace maker, internal defibrilator/cardioconverter

Impaired coagulation parameters

Unwillingness to be randomized to treatment

History of median laparotomy

Intraabdominal adhesions

Requirement for open laparoscopy

Contacts and Locations

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Please refer to this study by its ClinicalTrials.gov identifier: NCT01806012